drugset / Trial / NCT04919239
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts upon completion of 1 week of standard DS-TB treatment (cohort A), and another cohort of patients will be vaccinated upon completion of 1 month of standard MDR-TB treatment (cohort B). All the patients will be followed up to the end of the treatment.
Timeline
- Start
- 2021-09-22
- Primary completion
- 2025-06-19
- Completion
- 2025-06-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RUTI® | Vaccine | 25 ug | Intramuscular |